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Strike out all of line 17.

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In line 18 strike out the word "snch" and insert the words "an official."

Now, these are suggestions for amendment to this particular clause.

I want to refer to two other paragraphs. As to paragraph (b) of section 401 on page 15 that has already been commented on, and there is some question in our minds and apparently in the minds of several others as to whether or not this does not invalidate the.variation clause. For that reason we ask that this be stricken out. We also ask that it be stricken out for the reason that we cannot determine it will serve any good purpose.

Senator COPELAND. Your position is the same as Mr. Craig's in that matter?

Mr. BIGELOW. I did not hear what Mr. Craig had to say about it. In paragraph (g), page 17, we would like to have lines 18. 19, and line 21 and up to and including the period after the word "therein" stricken out. That is the paragraph with respect to the packaging and so on in accordance with the provisions of the Pharmacopoeia and the National Formulary. I think in some of our discussions, Senator Copeland. I brought out the point that the Pharmacopoeia and the National Formulary are books of standards for the retail druggists. And to apply the restrictions as to packaging and so on to a manufacturer on a commercial scale is an impractical proposition. For instance, take cinnamon bark. It says in the Pharmacopoeia, Preserve in tightly closed containers." We receive it in bags or bales.

As to chloroform the United States Pharmacopoeia says:

Preserve in well-stoppered bottles, in a cool place, protected from light. Proitect chloroform from contact with cork stoppers by covering them with tinfoil or other suitable material. Sold commercially in tins and ampoules. Digitalis is somewhat in the same classification as cinnamon bark. The United States Pharmacopoeia says:

Preserve in airtight containers. Sold commercially in large bales. Kept in lofts.

And another one is solution ferric chloride, the United States Pharmacopoeia says:

Preserve in glass-stoppered bottles, protected from light. Sold commercially in steel drums in bulk. Also sold at retail in cork-stoppered flint bottles.

There are several other examples that I might cite. In addition to that objection there has been some question raised as to whether or not this language might also invalidate the variation clause. I do not see myself what is to be accomplished by it.

As to paragraphs (j) and (k) in section 402, these are the so-called antiseptic and germicide clauses." AH I want to say about that is the same thing I have said to you on a number of occasions, Senator Copeland, and that is that we believe that these paragraphs should not be in the bill, and that the regulation of bactericides, germicides, and antiseptics should be left under the general provisions of the bill with respect to adulteration and misbranding. That has been our position. We feel that you are fixing standards, invariable standards, in this law that may retard progress.

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I have some other comments which I would like to have permission to file.

Senator CLARK. They may be filed.

Mr. BIGELOW. I want to say also that Dr. Anderson of E. R. Squibb & Son has filed a statement and suggested some amendments with which our association is in accord.

Here is my suggested amendment of section 401, paragraph (b): If its name is recognized in an official compendium, or if it purports to be a drug the name of which is so recognized, and it differs from the standard of strength, quality, identity, or purity as determined by the tests or methods of assay set forth therein; except that whenever tests or methods of assay have not been prescribed therein, or such tests or methods of assay as are prescribed are insufficient, for determining whether or not such drug complies with such standard, the Secretary is hereby authorized to bring such fact to the attention of the appropriate body charged with the revi sion of such compendium and if such body fails within a reasonable time to prescribe tests or methods of assay which are sufficient, then the Secretary may prescribe for the purposes of this act such tests or methods of assay by regulations as provided by sections 701 and 703. No drug shall be deemed to be adulterated under this paragraph if the standard of strength, quality, identity, or purity be plainly stated on its label although the standard may differ from that as determined by the tests or methods of assay set forth in an official compendium. Whenever a drug is recognized in both the United States Pharmacopoeia and the Homeopathic Pharmacopoeia of the United States it shall be subject to the requirements of the United States Pharmacopoeia unless it is labeled and offered for sale as a homeopathic drug, in which case it shall be subject to the provisions of the Homeopathic Pharmacopoeia of the United States and not to those of the United States Pharmacopoeia.

STATEMENT OF MISS ALICE L. EDWARDS, EXECUTIVE SECRETARY OF THE AMERICAN HOME ECONOMICS ASSOCIATION

Miss EDWARDS. Mr. Chairman and Senator Copeland, my name is Alice L. Edwards, executive secretary of the American Home Economics Association.

When the representatives of the 11 national organization appeared before your committee last Saturday, they expressed the earnest desire that S. 5 (Committee Print No. 3) with certain amendments as presented by Mrs. Harris T. Baldwin be speedily enacted by Congress.

As we have sat and listened to the testimony presented at this meeting we have been appalled as we have thought of the penalty society would have to pay should the recommendations of some of the witnesses be incorporated in this food, drugs, and cosmetic bill and be enacted by Congress.

We have noted with grave concern the efforts which are being made to weaken the enforcement provisions of the bill. We well realize we never can have the promised protection unless the enforcement provisions of the bill have teeth in them. It would appear that opposition has been directed against multiple seizures because this

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has proven the most effective weapon in the present law. We, therefore, protest against the consideration of proposed amendments which would hamper and even preclude enforcement.

The consumer organizations for which I speak insist that this bill provide proper standards for foods, drugs, and cosmetics.

We asked for multiple standards for food products. This bill makes no provision for them.

We have also protested against the striking out of that line in section 401 (b), line 22, on page 13, which provides that a drug shall be adulterated if its name is recognized in an official compendium and it fails to meet the definition and description set forth therein. Senator COPELAND. What page was that, Miss Edwards?

Miss EDWARDS. That is page 13, line 22. We find in the United States Pharmacopoeia relatively brief statements about the drugs listed. These usually include several sections, the first of which usually gives the definition and description, then followed by tests for identity and perhaps those concerning purity, assay, and other items. I understand for positive identification it is absolutely necessary in the case of many drugs that they conform in all respects to the definition and description. It is perfectly possible to have two substances quite different in their physiological effects which, nevertheless, so far as the tests and methods of assay prescribed in the United States Pharmacopoeia are concerned seem identical. Compliance with the full requirements of the Pharmacopoeia, not just the tests and methods of assay, is required to identify adequately these drugs.

It is only fair that any manufacturer who wishes to profit by the prestige given by the recognition of a drug in the Pharmacopoeia should be required to maintain in his product the standards set up for that product, the only variation to be permitted being in the strength of crude drugs used for the manufacture of finished products which comply with the United States Pharmacopoeia. If he wishes to manufacture a product varying from this standard he should be required to choose a name for it which definitely differs and differentiates it from the Pharmacopoeia product.

If a product is sold under the Pharmacopoeia name it should be composed of the substances it is supposed to contain; it should be made of products from the source designated. Otherwise it may not have the expected physiological effect.

It is no conciliation to an orphaned child to be assured that the ineffective drugs administered to his mother met the required chemical tests.

To require only partial conformity to Pharmacopoeia standards is to legalize a form of misbranding.

We have asked for the listing of ingredients on the label of all foods, drugs, and cosmetics. We believe we are perfectly justified in asking that these be given in the order of their predominance by weight. But if this order is not to be required we insist that at least the ingredients be given. It is essential in order that an individual may avoid products containing substances for which he or she may have an allergy. In other words, from recent developments in medical science we know the health of many persons is dependent upon their being able to obtain this information and avoid substances

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which are deleterious to them, although perfectly satisfactory for most other people to use.

Although we have voiced approval of S. 5, Committee Print No. 3, with the few amendments listed by Mrs. Baldwin, we wish to repeat that this bill represents a compromise. We are unwilling as consumers to make further concessions.

With each passing month women in our organizations are becoming more intelligently critical of the provisions in the bill, and will insist upon more protection, not less, as the passage of the bill is delayed. We have urged prompt action on this bill for we are not unmindful of the fact that continued delay is an economic injustice to consumers, and to some spells blindness, physical injury, or even death as menacing products continue on the market. We cannot, with peace of mind, brook unnecessary delay in the enactment of a bill to safeguard consumers of foods, drugs, and cosmetics.

May I later, Mr. Senator, file a bill of particulars stating the position of the 11 organizations regarding the amendments which have been proposed to this bill?

Senator CLARK. That will be allowed. (Statement referred to is as follows:)

STATEMENT ON POSITION CONCERNING S. 5 (COMMITTEE PRINT 3) AND PROPOSED AMENDMENTS THERETO

We wish to reiterate our statement of support of S. 5, committee print 3, and of desired amendments which Mrs. Harris T. Baldwin presented in her testimony on Saturday, March 2. Those which we consider of greatest importance are:

1. Retention of the original provision (h) in section 3 requiring that an identification of quality be placed on the labels of standard foods instead of the new paragraph (h).

2. Listing ingredients on the labels of foods and drugs, and for drugs the specifying of quantity or proportion of each active ingredient.

3. Addition of a provision requiring the listing of ingredients of cosmetics. 4. Amendment of section 303 to provide for the establishment of multiple quality standards for foods.

5. Amendment of section 401 (b) concerning the requirements for drugs listed in an official compendium by the restoration of line 22 which reads (1) fails to meet the definition and description set forth therein."

6. Amendment of section 501 (a) concerning deleterious substances in cosmetics by restoration of the words the user for which "health has been substituted.

7. Restoration of paragraph (h) of section 501 and section 503 concerning poisonous or deleterious substances in cosmetics.

8. Amendment of section 714, paragraph 4 so as to forbid the exportation of adulterated foods, drugs, and cosmetics.

However, during these hearings various amendments have been offered, certain of which if incorporated in this bill would, in our opinion, seriously weaken it and render it wholly inadequate for consumer protection.

1. We oppose a transfer of the enforcement of the advertising provision of the bill from the Food and Drug Administration to the Federal Trade Commission.

2. We oppose any further restriction of the provisions for multiple seizures. 3. We oppose a limitation of seizures to those approved by the court.

4. We oppose the proposed requirement that at least one seizure be made in the district where the product originated or the nearest possible district thereto.

5. We oppose any transfer of items in the definition of adulterated to the definition of misbranded foods, drugs, and cosmetics.

6. We oppose exemption of the requirement that the weight or the volume of cosmetics be shown on label.

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7. We oppose the omission of lines 12, 14. 15 of section 601 (6) providing for the addition of diseases to the list of those for which drugs may not be advertised to the public.

We are opposed to any further amendments which would lessen consumer protection.

Mrs. Alvin Barber, American Association of University Women; Mary A. Cindsley, American Dietetic Association: Harriet R. Howe, American Home Economics Association; Susan C. Francis, American Nurses Association; Margaret C. Maule, Girls Friendly Society of the U. S. A.; (Dr.) Lauretta E. Kress, Medical Women's National Association; Elizabeth Eastman, National Board of the Y. W. C. A. of the U. S. A.: Mary T. Bannerman. National Congress of Parents and Teachers; Louise G. Baldwin. (Mrs. H. T.), National League of Women Voters; Elizabeth Christman, National Women's Trade Union League: (Dr.) Julia M. Green, Women's Homeopathic Medical Fraternity.

Miss Wall.

STATEMENT OF MISS FLORENCE E. WALL, NEW YORK, N. Y.

Miss WALL. Mr. Chairman and Senator Copeland, my name is Florence E. Wall. I am a consulting chemist with 21 years' general experience, the last 10 years of which have been devoted to educational work, research, technical development, and publicity in the cosmetic industry and its practical application in beauty culture.

I have asked the privilege of appearing before you in order to express my broad approval of S. 5 insofar as it concerns cosmetics. To save time I wish to limit my remarks to the sections that refer to cosmetics.

Speaking unofficially, of course, and objectively, it is my opinion that the cosmetic industry as a whole could worry along very well with the provisions as they now stand. But I wish to offer a few suggestions that would not weaken the bill and which will assure us the provisions will be made more specific.

On page 2, line 13, since the early days of S. 1944. I have been suggesting that this clause about "all substances, preparations, and devices other than food, intended to affect the structure or any func tion of the body" is redundant. It has been already covered. If remedial claims are made they come under drug devices, and if the word" devices" is put into the definition of cosmetics, below, we shall have all these strange things accounted for that have been dubious before. All such apparatus as irons, scissors, nail files, and other things used in the beauty industry you have never had to consider before, and as you have them specified, those things are drugs. Mr. COPELAND. Could that all be omitted?

Miss WALL. That whole thing could be omitted, provided you put "devices" in the definition of a cosmetic below, Senator. I have checked it up and it seems to square very scientifically in every way with the kind of definition you need. I do not want to split hairs or go in for facetious comments on that. Many have been made.

I still say it seems silly to have to go to the Department of Agriculture for information about lipsticks, manicure preparations, and permanent-wave machines. Surely you do not want to promulgate the idea that you think a permanent-waving machine, manicure scissors, razors, and the nose shapers that we discussed before